Kornimate/medical-research-clean huggingface dataset:
prct001 aquablation therapy outcomes in prostate cancer patients

Conditions: Benign Prostatic Hyperplasia; Localized Prostate Cancer

Summary: the goal of this clinical trial is to assess the performance and safety of the aquabeam robotic system for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (luts) and are diagnosed with localized prostate cancer. participants will go through baseline and follow up assessments up to 12 months.


Eligibility criteria:
inclusion criteria: * international prostate symptom score (ipss) ≥ 8 * gleason grade group 1-3 * prostate-specific antigen (psa) ≤20ng/ml * cancer stage less than or equal to t2c exclusion criteria: * patients with previous surgical treatment of benign prostatic hyperplasia * mri evidence of extracapsular extension of cancer * any severe illness that would prevent complete study participation or confound study results

Keywords: aquabeam aquabeam robotic system aquablation aquablation therapy robotic waterjet treatment rwt prostate cancer lower urinary tract symptoms luts bph
sole local anesthetic versus opioid plus local anesthesia in epidural labor analgesia

Conditions: Pain

Summary: it is common for obstetric anesthesia using opioid supplement to local anesthetics for epidural labor pain control. given the low doses of these epidural drugs, we never doubt the necessity of the supplement of opioid to lacal anesthetics during this process based on the concept that opioid addition can enhance and prolong the analgesic effect of local anesthetics. however, we unavoidably encounter many opioid-associated side effects during the labor delivery. in addition, usage of opioid increase the medical cost for each patient. we herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor pain control.


Eligibility criteria:
inclusion criteria: * nulliparas * request epidural analgesia * chinese exclusion criteria: * allergic to opioid or local anesthetics * fail to perform epidural puncture and catheterization * organ dysfunction * contraindications for epidural anesthesia

Keywords: opioid local anesthetic labor delivery safety
sepsis prediction by monocyte distribution width and procalcitonin

Conditions: Sepsis; Diagnoses Disease

Summary: the mortality rate of sepsis remains as high as 30 to 40%. early diagnosis and treatment of patients with sepsis reduce mortality significantly. the most commonly used biomarkers in clinical practice are c-reactive protein (crp) and procalcitonin (pct). in terms of exploring new diagnostic tools of sepsis, monocyte distribution width (mdw) was first reported in 2017. it was reported as part of the white blood cell (wbc) differential count. mdw greater than 20 and abnormal wbc count together were reported to provide a satisfactory accuracy. the area under curve (auc) in predicting sepsis-2 is 0.852. it was proposed as a novel diagnostic tool of sepsis in the emergency setting. nonetheless, the performance of mdw compared with the conventional biomarkers remained unknown. the aim of this study was to compare the diagnostic accuracy of mdw and pct on sepsis in the emergency department.


Eligibility criteria:
subject inclusion criteria * adult ≥20 years) subjects presenting to the ed with the chief complaints of fever, altered consciousness, hypotension, and dyspnea. cbc with differential testing performed, at presentation as part of their standard medical care. * subjects who have signed informed consent. subject exclusion criteria * previously enrolled in this study (i.e. subjects may not be enrolled more than once in this study) * subjects discharged from the ed \<72 hours * pregnant women * subjects not able to understand or sign informed consent

Keywords: sepsis procalcitonin mdw
application of indicator based-electrical impedance tomography method assess lung regional perfusion in icu patients

Conditions: Respiratory Failure; Hypoxemia; ARDS, Human

Summary: this study is an observational study. investigate the relationship of oxgenation and lung regional ventilation and perfusion assessed by the indicator based-eit method in the critically ill patients in icu

1. written informed consent was obtained from all patients or next of kin before data were included in the study. 2. when the research team was available, adult patients within 1w, who were sequentially admitted to the department of critical care medicine and required central venous catheters for resuscitation were eligible for the study. 3. information collected at enrollment included demographic characteristics such as age, sex, acute physiology and chronic health evaluation ii score (apcheii); . the global hemodynamic, respiration condition and pao2 were measured. at the same time, the lung regional ventilation and perfusion assessed by the indicator based-eit method(injection 10%nacl). 4. the 10%nacl was injected by the central venous catheter.

Eligibility criteria:
inclusion criteria: * time of admission icu \< 7days * age (\> 18 years old) * have been placed central venous catheter based on clinical requirement exclusion criteria: .chest skin injured and cannot be monitored by eit. * severe hypernatremia * pregnancy

Keywords: eit, pulmonary perfusion
treatment of insomnia in elderly sleep apnea patients with ramelteon (tak 375)

Conditions: Insomnia; Obstructive Sleep Apnea

Summary: the objective of the study is to determine if treatment with ramelteon will help to improve insomnia in older adults with co-existent insomnia and sleep apnea. the primary study objective is sleep latency (a measure of insomnia). the hypothesis is that sleep latency will be reduced in subjects taking ramelteon relative to the placebo arm. the secondary study objective is to determine if subject compliance with cpap treatment of their sleep apnea is improved in subjects taking ramelteon (their compliance may be improved because they would have less insomnia due to ramelteon treatment when using their cpap). the hypothesis is that compliance with cpap will be improved in subjects taking ramelteon relative to the placebo arm.

randomized, double-blind, placebo-controlled, parallel arm clinical trial with two study arms.

Eligibility criteria:
inclusion criteria: * obstructive sleep apnea * insomnia * age\>60 exclusion criteria: * cognitive impairment * active alcohol or substance abuse * active use of other sedative-hypnotic agents * active use of fluvoxamine (drug interaction with ramelteon * evidence of hepatic dysfunction (ramelteon contraindicated) on liver function panel * presence of periodic limb movement disorder or restless legs syndrome * severe chronic obstructive pulmonary disease
muscle oxygenation in stroke patients

Conditions: Stroke

Summary: in addition to its many effects, physical movement is known to change both systemic blood circulation and muscle blood flow. in a study examining the effects of motor imagery, which produces effects similar to physical movement, on muscle oxygenation, no change in muscle oxygenation was detected with motor imagery. however, no study has been found examining muscle oxygenation along with motor imagery in stroke patients. however, it has not been investigated whether there is a difference in muscle oxygenation between the affected and less affected extremities after stroke. for this reason, our study was planned to examine the effect of motor imagery on lower extremity muscle oxygenation in stroke patients. in addition, in our study, we will examine whether there is a difference in muscle oxygenation between the affected and less affected extremities in stroke patients under different conditions (rest / physical movement / motor imagery (mental movement)). since there are insufficient studies in this field in the literature, we think that our study will lead to future studies.


Eligibility criteria:
inclusion criteria: * being between the ages of 40-75 * being diagnosed with stroke * bmi \<30kg/cm2 * subcutaneous fat thickness \<12mm * mini mental state test score being 24 or above exclusion criteria: * having another musculoskeletal, cardiovascular, pulmonary, metabolic or neurological disease that is serious enough to prevent participation in the study * having serious vision and hearing problems * presence of serious cognitive impairment determined by the physician that would prevent the tests from being performed * presence of an open wound or infection in the area to be measured

Keywords: motor imagery muscle oxygenation
novel donor site dressing (product x)

Conditions: Burns

Summary: the goal of this clinical trial is to test a novel donor site dressing called product x in burn patients requiring skin grafting procedures. a donor site is an area where the surgeon has taken a layer of skin to create a graft. this is required to make severe burn wounds heal. however, donor sites often experience infection, pain, and itch that can delay the healing of the donor site. to prevent these complications, donor sites are covered with dressings to prevent infection and absorb fluids from the wounds. many options exist, but no single dressing is best, especially for pain management and the ability to absorb fluids from wounds effectively. the investigators have developed a new donor site dressing to meet the criteria of an "ideal dressing," called product x. the main question this clinical trial aims to determine the safety and potential wound-healing benefits of this donor site dressing as a new therapy that will help patients who require donor sites. participants will: * be randomized, like a flip of a coin, to receive either product x or the standard-of-care dressings. if patients have one donor site, it will be randomized to receive either product x or the standard-of-care dressings, allevyn and xeroform. if they have two donor sites, one donor site will be randomized to receive product x and the other to receive standard-of-care dressings. * have photographs of their donor sites taken at the operation, during dressing changes, at discharge, and at regularly scheduled outpatient follow-up appointments with the burn clinic. * complete short questionnaires to assess their comfort (pain and itch) with their donor sites daily. * complete a scar formation questionnaire at your regularly scheduled follow-up appointments in the outpatient burn clinic. researchers will compare product x to standard-of-care dressings (allevyn and xeroform) to see if there are improvements in wound healing, pain, itch, and infection.


Eligibility criteria:
inclusion criteria: 1. ≥18 years of age; 2. \<25% total body surface area (tbsa) burn; 3. deep partial or full-thickness burn requiring operative procedures; 4. autologous donor site(s) on thigh, torso, and/or arm. exclusion criteria: 1. patients who are moribund. 2. pregnancy. 3. active cancer and currently undergoing treatment.

Keywords: donor site burns wound healing
evaluation of risk factors regarding extubation failure in severe brain injured patients.

Conditions: Severe Brain Injury

Summary: severe brain-injured patients require prolonged mechanical ventilation. weaning these patients from mechanical ventilation is challenging. during neurologic recovery, brain injured patients usually present satisfactory respiratory autonomy. however, the exact timing of extubation is unknown and is frequently delayed because of potential inhalation. to date, there are no clinical signs available in the current literature that can help the attending physician in the decision-making process of extubation in brain-injured-patients


Eligibility criteria:
inclusion criteria: * patients with brain-injury (traumatic brain injury, subarachnoid haemorrhage, stroke, intracerebral hemorrhage, brain tumour) requiring ≥ 48 hours of mechanical ventilation after admission exclusion criteria: * pregnant women * patient consent withdrawal

Keywords: brain-injury extubation
total fat pad excision leads to worse isokinetic performance in total knee arthroplasty

Conditions: Osteoarthritis, Knee; Knee Arthritis

Summary: there are concerns that total infrapatellar fat pad (ipfp) excision in total knee arthroplasty (tka) results in patellar tendon shortening due to ischemic contracture. but, individual preference of the surgeon is still the main determinant between total or partial excision. the aim of this randomized controlled trial is to compare knee society score (kss), knee extension and flexion peak torque in patients undergoing tka with total ipfp excision or partial ipfp excision. the hypothesis of the study is that during tka, total ipfp excision would lead to worse isokinetic performance and clinical outcome. a total of 72 patients scheduled to undergo tka for primary osteoarthritis of the knee by a single surgeon were randomly assigned to either the total or partial excision group. patients were evaluated preoperatively and at postoperative 1 year, with knee society score (kss) and isokinetic measurements. physiatrist doing isokinetic tests and patients were blinded to the study.


Eligibility criteria:
inclusion criteria: * age between 55 and 80 years * scheduled to undergo unilateral tka on for primary knee osteoarthritis exclusion criteria: * inflammatory arthritis * post-traumatic osteoarthritis * previous knee surgery * neuromuscular diseases * bilateral tka * insufficiency of collateral ligaments

Keywords: infrapatellar fat pad total knee arthroplasty isokinetic test strength
fed study of mylan nitrofurantoin monohydrate/macrocrystals capsules 100 mg and macrobid® capsules 100 mg

Conditions: Healthy

Summary: the objective of this study was to investigate the bioequivalence of mylan nitrofurantoin monohydrate/macrocrystals capsules to procter \& gamble macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed conditions.


Eligibility criteria:
inclusion criteria: * healthy, adult subjects, 18 years and older * able to swallow medication exclusion criteria: * institutionalized subjects * history of any significant disease * use of any prescription or otc medications within 14 days of start of study * received any investigational products within 30 days prior to start of study
swog-9023, dna analysis of tumor tissue from patients with metastatic kidney cancer

Conditions: Kidney Cancer

Summary: rationale: dna analysis of tumor tissue may help doctors predict how well patients will respond to treatment. purpose: this laboratory study is analyzing the dna in tumor tissue from patients with metastatic kidney cancer.

objectives: * determine if cytogenetic abnormalities can predict clinical outcome, in terms of response to treatment and survival, in patients with metastatic renal cell carcinoma registered to the nephrectomy arm (arm i) of swog-8949. * correlate cytogenetic abnormalities and dna content analysis (dna index and s-phase fraction) with clinical outcome. outline: this is a partially prospective, partially retrospective, multicenter, companion study. paraffin-embedded tumor tissue specimens from patients enrolled in swog-8949 are evaluated by cytogenetic analysis (e.g., presence of trisomy and loss of y chromosome) and flow cytometric analysis (e.g., presence of nondiploid cells and presence of abnormal proliferation index). projected accrual: a total of 80 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of renal cell carcinoma * any t, any n, m1 disease as specified in swog-8949 * eligible for and registered on the nephrectomy arm\* (arm i) of swog-8949 note: \*patients must be registered on this study before undergoing nephrectomy on swog-8949 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: stage iv renal cell cancer
dynamic laryngeal opening for bilateral vocal fold paralysis by an implanted stimulator

Conditions: Vocal Cord Paralysis

Summary: people who had paralysis of the vocal cords are often prevented from breathing by this problem because the cords will not open, and the patients have to wear a tracheostomy (neck breathing tube) to bypass this airway obstruction. this study examines the effects of vocal cord opening triggered by a pacemaker implanted over the chest wall. the device is connected to a nerve taken from a muscle close to the larynx (voice box) and implanted into the paralysed laryngeal muscle so it can reinnervate it. when this process is complete after a few weeks, the stimulator is turned on and the level of vocal cord opening is assessed. airway improvement is checked by pulmonary function tests and measurements of vocal cord opening. the ultimate goal of the study is to lead to situations where patients with bilateral vocal fold paralyses could get rid of the neck breathing tube to have less complications, be more comfortable and socially acceptable.

data pending

Eligibility criteria:
inclusion criteria: * breathing difficulties from vocal cord paralyses * tracheostomy tube * ability to understand the purpose of the research * appropriate hand motor coordination exclusion criteria: * lack of understanding the research * poor hand motor coordination * non-acceptance of tracheostomy * inability to passively move the paralyzed vocal cords

Keywords: bilateral vocal cord paralyses implanted laryngeal stimulator vocal cord opening pulmonary function tests
a phase 2 open-label pilot study evaluating myk-461 in subjects with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction

Conditions: Cardiomyopathy, Hypertrophic Obstructive; Left Ventricular Outflow Tract Obstruction

Summary: the purpose of this phase 2 open-label pilot study is to evaluate the efficacy, pharmacokinetics (pk), pharmacodynamics (pd), safety, and tolerability of myk-461 in subjects with symptomatic hcm and lvot obstruction aged 18-70 years.


Eligibility criteria:
key inclusion criteria: * diagnosed with hcm (hypertrophied and non-dilated left ventricle in absence of systemic or other known cause), with lv wall thickness ≥ 15 mm at time of initial diagnosis or ≥ 13 mm with a positive family history of hcm. * age 18-70 * bmi 18-37kg/m2 * documented lvef ≥ 55% at the screening visit as determined by the investigator and the investigational site's echocardiography laboratory. * resting lvot gradient ≥ 30 mg hg and post-exercise peak lvot gradient ≥ 50 mm hg * nyha functional class ii or higher key exclusion criteria: * history of sustained ventricular tachyarrhythmia. * history of syncope with exercise within past 6 months. * active infection. * persistent atrial fibrillation or atrial fibrillation at screening or history of paroxysmal atrial fibrillation with resting rate document \> 100bpm within 1 year of screening. * has qtc fridericia (qtcf) \> 500 ms, or any other ecg abnormality considered by the investigator to pose a risk to subject safety (e.g. second degree atrioventricular block type ii). * aortic stenosis or fixed subaortic obstruction. * history of lv systolic dysfunction (lvef \< 45%) at any time during their clinical course. * history of obstructive coronary artery disease. * history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or myokardia physician, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. * part a: ongoing therapy with beta blockers, calcium channel blockers, or disopyramide. subjects on any of these medications who, in the opinion of the investigator, can safely be withdrawn are eligible as long as medication is discontinued at least 14 days prior to the screening visit. * part b: ongoing therapy with calcium channel blockers or disopyramide. subjects on any of these medications who, in the opinion of the investigator, can safely be withdrawn are eligible as long as medication is discontinued at least 14 days prior to the screening visit. * prior treatment with cardiotoxic agents such as doxorubicin or similar, or current treatment with antiarrhythmic drugs that have negative inotropic activity, e.g. flecainide or propafenone.
comparison of the dana to the anam in the evaluation of cognitive changes after concussion

Conditions: Traumatic Brain Injury; Brain Concussion

Summary: the defense automated neurobehavioral assessment (dana) was recently developed as a durable, portable, and "field-hardened" neurocognitive assessment tool. the purpose of this study is to compare the sensitivity of the dana brief exam with the automated neuropsychological assessment metrics (anam) battery currently used by the military after concussion. the primary hypothesis is that the dana brief exam will be more sensitive for detecting continued impaired cognitive performance than the anam during recovery after a concussion.

among active duty military personnel deployed to combat theaters, blast injury is a leading cause of traumatic brain injury (tbi). service members with tbi can experience notable neurological impairments-e.g., attention disturbances, memory and language deficits, and delayed reaction time. cognitive performance can still be impaired 2-4 weeks after concussion with no overt physical symptoms. thus, there is a critical need to have an efficient means to determine the incidence of cognitive deficits in service members exposed to or injured by blasts. to that end, this study plans to evaluate the anam and the dana to determine which neurocognitive test more reliably and accurately detects cognitive impairments during the recovery period from a concussion.

Eligibility criteria:
inclusion criteria: * active-duty u.s. military service members * clinical diagnosis of concussion/mild traumatic brain injury (mtbi) (as defined by the american congress of rehabilitation, 1993, and dod), made by the treating clinician based on clinical history, examination and/or clinical imaging performed as part of standard of care. this includes subjects with concussion from any mechanism (blast-related, blunt trauma etc.)--for concussed subjects only * glasgow coma scale (gcs) score of 15 as assessed by the consenting research staff--for concussed subjects only * concussive event that occurred within 72 hours of injury (to exclude service members presenting due to lingering effects of a previous injury)--for concussed subjects only * willingness to participate in the study, ability to communicate and comply with the study protocol and ability to provide informed consent. exclusion criteria: * have a history of other mtbi within 90 days, moderate brain injury within the past 3 years, or any lifetime history of severe brain injury * history of a documented diagnosis of post traumatic stress disorder (ptsd) or of treatment for ptsd * taking psychoactive medications, opioids, or other significant sedating medication * individuals with severe psychiatric disorders requiring continuing medication or recent treatment for an alcohol or drug dependency * report a pain level of 8 or greater on the 10-point likert scale of 1 to 10 (e.g., 8, 9 or 10).

Keywords: dana anam concussion mild traumatic brain injury